Reported Dec 20, 2023 · Ongoing
The System is designed as a modular system with components that include an Overhead Tube Suspension with…
GE Hangwei Medical Systems, Co. Ltd.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: GE Hangwei Medical Systems, Co. LTD · West Area Bldg. 3, No.1 Yongchang North Road · Beijing, N/A · N/A
Is this the product you have?
- The System is designed as a modular system with components that include an Overhead Tube Suspension with tube/collimator, wallstand, Table, X-ray generator, and cleared wireless digital detectors. The list of detectors verified and validated for use with the Discovery XR656 HD system, including their specifications, are provided in the user documentation. The System generates diagnostic The components may be combined in different configurations to meet specific customer needs. In addition, upgrade configurations are available for predicate devices. The optional image pasting function enables the operator to stitch sequentially acquired radiographs into a single image. This 510(k) is to incorporate the VolumeRad advanced application that was currently available on the Discovery XR656 product onto the Discovery XR656 HD, as well as introduce a new Metal Artifact Reduction Algorithm, and an optional standalone console to take any HelixTM acquired images via DICOM (such as from a Discovery XR656 HD, Optima XR646 HD, or Optima XR240amx) and process the images independently of the system it was acquired on.
- Lot codes and dates
134 of 134 products
Products covered by this recall # Product as published 1 UDI 01001952781183561122100021DX3SS2200214HL, System ID 205620DEF1 2 UDI 01001952781183561122080021DX3SS2200165HL, System ID 205783DEF1 3 UDI 01001952781183561122100021DX3SS2200211HL, System ID 205387DEF1 4 UDI 01001952781183561122110021DX3SS2200216HL, System ID 623ABZARRWTMPO 5 UDI 01001952781183561122120021DX3SS2300001HL, System ID 928263DEF1 6 UDI 01001952781183561123040021DX3SS2300103HL, System ID 520NOGTEMPO 7 UDI 01001952781183561122100021DX3SS2200210HL, System ID 602ABZSCOTTSTMPO 8 UDI 01001952781183561122110021DX3SS2200223HL, System ID 602ABZCNTRLTMPO 9 UDI 01001952781183561123030021DX3SS2300082HL, System ID 209324DEF1 10 UDI 01001952781183561123020021DX3SS2300046HL, System ID 209497DEF1 11 UDI 01001952781183561122080021DX3SS2200158HL, System ID 303827DEF1 12 UDI 01001952781183561123010021DX3SS2300030HL, System ID 970242DEF1 13 UDI 01001952781183561122080021DX3SS2200168HL, System ID 303457DEF1 14 UDI 01001952781183561122030021DX3SS2200047HL, System ID 860545TEMPO1 15 UDI 01001952781183561122030021DX3SS2200046HL, System ID 860545TEMPO2 16 UDI 01001952781183561122010021DX3SS2200013HL, System ID 203838TEMPO 17 UDI 01001952781183561122070021DX3SS2200117HL, System ID 860889TEMPO 18 UDI 01001952781183561123010021DX3SS2300013HL, System ID 202444DEF2 19 UDI 01001952781183561123040021DX3SS2300135HL, System ID 202877TEM1 20 UDI 01001952781183561123020021DX3SS2300039HL, System ID 813681DEF1 - Amount recalled
- 134 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
GE HealthCare has become aware of the potential that incorrect torque has been applied to certain bolts of the Definium Tempo and Definium Tempo Pro products which may result in a potential fall of elements of the Overhead Tube Suspension (OTS) assembly.
This product could cause temporary or reversible health problems — stop using it.
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